Surgical Manipulation of the Aorta and Cerebral Infarction

Stroke Clinical Trial

Official title:

Surgical Manipulation of the Ascending Aorta and Cerebral Infarction Following CABG

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00558779
• Other study ID #: 49/07
• Secondary ID: F/13/03
• Status: Recruiting
• Phase: Phase 2
• First received: November 14, 2007
• Last updated: November 21, 2007
• Start date: November 2007
• Est. completion date: May 2010

Study information

• Verified date: November 2007
• Source: University of Wuerzburg
• Contact: Wilko Reents, MD
• Phone: 0049 - 931 - 201 - 33001
• Email: reents_w[@]klinik.uni-wuerzburg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare two surgical strategies for coronary artery bypass grafting with respect to the occurrence of cerebral infarctions made visible by magnetic resonance imaging

Description:

Stroke is one of the most devastating complications following coronary artery bypass grafting (CABG) with an overall incidence ranging from 2.0 % to 3.2 %. The presumed etiology for the majority of strokes after CABG is atheroembolism from the diseased aorta ascendens caused by surgical manipulation. Off-pump coronary artery bypass grafting (OPCAB) allows the construction of bypass grafts without surgical manipulation of the aorta. Yet a trial comparing different surgical strategies with stroke as the primary end point would require several thousand patients to achieve an adequate statistical power. The number of patients can be substantially reduced, if cerebral damage is assessed by diffusion-weighted magnetic resonance imaging (DW-MRI). Using DW-MRI we have recently demonstrated that 25% of a patient population undergoing CABG without an increased risk of stroke showed new cerebral infarctions. These new cerebral lesions all showed an embolic pattern, became visible at T2-weighted images and were clinically silent, e .g. did not cause a new focal neurologic deficit. Given the much higher frequency of cerebral lesions assessed by DW-MRI than clinically apparent stroke, DW-MRI is an ideal surrogate parameter for the assessment of cerebral damage in patients undergoing CABG.

The aim of the study is therefore, to investigate the influence of the surgical technique on the occurence of new ischemic cerebral lesions as assessed by DW-MRI in patients undergoing CABG in a prospective randomized setting. We hypothesize that OPCAB, which enables sparing of aortic manipulation, will reduce cerebral infarctions in patients with an increased risk for perioperative stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• age > 72

• history of stroke

• cerebrovascular artery disease with stenosis > 50%

• peripheral arterial disease.

Exclusion Criteria:

• urgent or emergency operation

• unstable angina

• reoperation

• concomitant valvular disease requiring surgery

• implanted pacemaker or other incorporated ferromagnetic material

• claustrophobia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Infarction
• Myocardial Ischemia
• Stroke

Intervention

Procedure:
• OBCAB (Off Pump Coronary Artery Bypass Grafting)
OPCAB with sparing of aortic manipulation (eg, no aortic cannulation for cardiopulmonary bypass, no aortic cross-clamp, no side-clamping of the aorta). Graft anastomosis to the central circulation with y-grafts on the arteria thoracica interna or on the aorta with help of the Heart-string-system (Guidant)
• CABG (coronary artery bypass grafting)
conventional CABG with cardiopulmonary bypass

Locations

Country	Name	City	State
Germany	Department of Cardiothoracic Surgery, University Hospital Wuerzburg	Wuerzburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Wuerzburg	Deutsche Stiftung für Herzforschung

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Bendszus M, Reents W, Franke D, Müllges W, Babin-Ebell J, Koltzenburg M, Warmuth-Metz M, Solymosi L. Brain damage after coronary artery bypass grafting. Arch Neurol. 2002 Jul;59(7):1090-5. — View Citation

Calafiore AM, Di Mauro M, Teodori G, Di Giammarco G, Cirmeni S, Contini M, Iacò AL, Pano M. Impact of aortic manipulation on incidence of cerebrovascular accidents after surgical myocardial revascularization. Ann Thorac Surg. 2002 May;73(5):1387-93. — View Citation

Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. — View Citation

Sellke FW, DiMaio JM, Caplan LR, Ferguson TB, Gardner TJ, Hiratzka LF, Isselbacher EM, Lytle BW, Mack MJ, Murkin JM, Robbins RC; American Heart Association. Comparing on-pump and off-pump coronary artery bypass grafting: numerous studies but few conclusions: a scientific statement from the American Heart Association council on cardiovascular surgery and anesthesia in collaboration with the interdisciplinary working group on quality of care and outcomes research. Circulation. 2005 May 31;111(21):2858-64. — View Citation

Stamou SC, Hill PC, Dangas G, Pfister AJ, Boyce SW, Dullum MK, Bafi AS, Corso PJ. Stroke after coronary artery bypass: incidence, predictors, and clinical outcome. Stroke. 2001 Jul;32(7):1508-13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence and number of cerebral infarctions assessed by magnetic resonance imaging		2-7 days after surgery
Secondary	mortality		within hospital stay following surgery
Secondary	stroke		within hospital stay following surgery
Secondary	delirium		within hospital stay following surgery
Secondary	neurocognitive performance		within hospital stay following surgery
Secondary	multi-organ failure		within hospital stay following surgery
Secondary	myocardial infarction		within hospital stay following surgery
Secondary	completeness of revascularisation		within hospital stay following surgery